Operations NPI Manager

HistoSonics, Inc.

$110K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Operations, Supply Chain, or related field.
  • 8+ years of experience in operations, manufacturing engineering, or program management, particularly in NPI environments.
  • Medical device industry experience.
  • Experience in establishing NPI processes from scratch.
  • Track record of leading complex product launches from prototype to production.
  • Strong knowledge of manufacturing processes and supply chain fundamentals.
  • Proficient in stage-gate product development methodologies.

Responsibilities

  • Lead complex operations projects for new product development and manufacturing support.
  • Collaborate with teams from concept through mass production as operations lead.
  • Influence design for manufacturability and track project timelines and risks.
  • Coordinate with supply chain and procurement to ensure supplier readiness.
  • Implement operational readiness, including equipment integration and regulatory compliance.
  • Develop processes to meet specifications and performance criteria.
  • Track NPI metrics and conduct post-launch reviews for continuous improvement.

Benefits

  • Health, dental, and vision insurance.
  • Life, short-term, and long-term disability insurance.
  • 401(k) retirement plan.
  • Paid time off.
  • Comprehensive benefits package for full-time employees.
Full Job Description
Location: Madison, WI

Position Summary (Why this role matters):

We are seeking an experienced Operations NPI Manager to own the end-to-end process of transitioning new products from engineering/design into full-scale manufacturing and operations. This role sits at the intersection of Engineering, Supply Chain, Quality, and Manufacturing, ensuring new products launch on time and meet operational readiness requirements. The Operations NPI Manager leads moderate to highly complex operations projects with minimal direction, working cross-functionally and globally to drive successful product introductions.

Key Responsibilities (What you'll do):
  • Lead multiple moderate to highly complex operations projects for NPD, process improvement, and manufacturing support; provide project management and technical problem-solving support on high-complexity projects as needed; consistently visualize the entire scope of a project.
  • Partner with cross-functional New Product Introduction (NPI) programs from concept through mass production, serving as the operations owner throughout the product lifecycle.
  • Partner with Product Development/Engineering teams during design phases to influence design-for-manufacturability (DFM) and design-for-cost (DFC). Track project schedules to ensure adherence to timelines, keeping the operations team and management informed of issues; identify and mitigate project risks, implement risk-reduction plans, and escalate as appropriate.
  • Coordinate with Supply Chain and Procurement to communicate potential new suppliers and manage components/material readiness - confirming new suppliers have been qualified, parts/components are on order, and operations processes have been created and updated as needed.
  • Work cross-functionally and globally with Quality & Reliability, Engineering, Sourcing, Finance, Supply and Demand, Marketing, and other departments.
  • Lead operational readiness and implementation; accountable for operational elements of project execution, including integration of equipment and tooling, capability reviews, manufacturing process, and safety, regulatory, and standards compliance.
  • Interact with operations, quality, and suppliers to develop processes capable of meeting part/product specifications and performance requirements.
  • Establish and track key NPI metrics, including on-time launch.
  • Lead post-launch reviews and drive continuous improvement into future programs.
  • Communicate program status, risks, and decisions to the Operations organization.

Qualifications and Skills:
  • Bachelor's degree in Engineering, Operations, Supply Chain, or related field.
  • 8+ years of experience in operations, manufacturing engineering, or program management, with significant time in NPI or new product launch environments.
  • Experience in medical devices.
  • Experience building NPI processes from the ground up.
  • Proven track record leading complex, cross-functional product launches from prototype to volume production.
  • Strong understanding of manufacturing processes, DFM/DFx principles, and supply chain fundamentals.
  • Experience with stage-gate or similar product development processes.
  • Excellent program management skills.
  • Strong communication skills, comfortable presenting to senior leadership and cross-functional, global teams.
  • Experience with ERP/PLM systems (e.g., SAP, Oracle, Agile, Windchill).

Preferred Qualifications
  • Six Sigma / Lean Manufacturing certification.


Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

#LI-remote

Similar Jobs

More Jobs at HistoSonics, Inc.

More Pharmaceuticals & Biotech Jobs

Find similar Operations NPI Manager jobs: